UNIarray^®

Innovation in Protein Biochips

As an innovator in protein biochips, Protagen has developed UNIarray^®, a technology platform for the development of diagnostics.

Systematic identification of auto-antibody signatures

UNIarray^® allows the systematic identification of proprietary auto-antibody signatures in blood for the development of new In-vitro diagnostics and companion diagnostics for patient stratification and therapy selection. The fundamental principle of this technology portfolio is based upon the fact that during a lifespan every person produces antibodies directed against human antigens (proteins) in addition to those - more well-known - antibodies directed against pathogens such as bacteria and viruses. The production of these so-called auto-antibodies reflect the immune response to a continuous remodelling of cells or tissues caused by a chronic disease process. Usually, auto-antibodies do not cause an easily identifiable disease. In contrast, in auto-immune diseases the auto-antibodies may be causing clinical symptoms, i.e. a disease like rheumatoid arthritis.

In the case of auto-antibodies, the immune system has already responded by producing such antibodies against especially important proteins in the course of a disease. These antibodies can be detected by presenting their corresponding proteins (auto-antigens).

World's largest collection of recombinant human protein expression libraries

Protagen has developed the worldwide largest collection of recombinant human protein expression libraries derived from fetal brain, liver, CD4+ T-cell, lung and colon expressed in E. coli expression as His-tagged fusion proteins. One of these libraries represents more than 10,000 recombinant human proteins spotted on one chip. The interaction of auto-antibodies from patient samples with these potential antigens can be detected very fast with high efficiency and enables an unbiased search for novel blood based auto-antibodies combined with a high degree of automation in the downstream workflow. Using this process, Protagen has discovered unique biomarkers for indications like autoimmune diseases, cancer, inflammatory diseases and neurodegenerative disorders which have been successfully validated in internal discovery and development programs.

Auto-antibodies vs genomic based markers

There are numerous advantages of using auto-antibodies in serum/plasma compared to genomic based markers in diagnostic applications:

• One particular feature is their specific structure and stability. If stored properly they are stable in patient serum, plasma, or cerebrospinal fluid practically infinitely.
• They are present in serum or plasma in high concentrations. This enables the use of very robust and, therefore, very reproducible assay schemes for detection and quantification.
• Due to their specificity and high affinity binding to their corresponding auto-antigen, no enrichment or elaborated sample preparation is required. Essentially, enrichment occurs automatically during analysis by binding of the auto-antibodies to the auto-antigen.
• Antibodies are not subject to circadian rhythms or other short-term changes in physiological states. This means that sampling can occur any time because results are not influenced by the time of day of sampling or nutritional status.

The UNIarray^® technology platform is a patent-protected technology platform originating from the Max-Planck-Institute for Molecular Genetics in Berlin, Germany.